Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy

NCT ID: NCT05723042

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2023-03-28

Brief Summary

Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.

It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.

Conditions

Erb's Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EMS with CIMT group

Group Type: EXPERIMENTAL

EMS with CIMT

Intervention Type: OTHER

The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.The assisting hand assessment AHA was used to measure bimanual activity performance at baseline,8 weeks, 16 weeks. 20-minute application of currents and resistance exercises for the respective muscles of the area. The intervention group with 11 patients underwent a program of CIMT for one hour daily for 14 consecutive days or two hours per day, six days per week and a total of 12 weeks. A follow-up will be performed 12 weeks after the intervention. The healthy upper limb will be immobilized by orthosis or cast for six hours a day . Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction

EMS Group

Group Type: ACTIVE_COMPARATOR

EMS

Intervention Type: OTHER

this group will only receive baseline exercises (ROM and flexibility exercises) than apply electrical stimulations at specific motor points. Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction

Interventions

EMS with CIMT

The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.The assisting hand assessment AHA was used to measure bimanual activity performance at baseline,8 weeks, 16 weeks. 20-minute application of currents and resistance exercises for the respective muscles of the area. The intervention group with 11 patients underwent a program of CIMT for one hour daily for 14 consecutive days or two hours per day, six days per week and a total of 12 weeks. A follow-up will be performed 12 weeks after the intervention. The healthy upper limb will be immobilized by orthosis or cast for six hours a day . Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction

Intervention Type: OTHER

EMS

this group will only receive baseline exercises (ROM and flexibility exercises) than apply electrical stimulations at specific motor points. Electrotherapy will be applied with TENS for 15 minutes at intervals of 1000ms and with a pulse duration of 50ms. The square wave will be chosen to ensure that there will be sufficient muscle contraction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged between 2.5 to 8 years years
• Clinically diagnosed with erb's palsy/brachial plexus palsy
• Ability to cooperate with assessments and therapy
• Full passive ROMs in all motions at the shoulder, elbow, and wrist joints

Exclusion Criteria

• Cognitive impairment
• Contracture in the affected upper extremity
• Injured unaffected arm
• Visual problems likely to interfere with treatment/testing
• Previous orthopedic or neurological surgery
• Previous application of CIMT

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muneeb Iqbal, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Jinnah Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Gonçalves RV, Araujo RCd, Ferreira VKG. Effect of reaching training combined with electrical stimulation in infants with brachial plexus palsy: a single subject design. Fisioterapia e Pesquisa. 2021;28:32-8.

Reference Type: BACKGROUND

Justice D, Awori J, Carlson S, Chang KW, Yang LJ. Use of neuromuscular electrical stimulation in the treatment of neonatal brachial plexus palsy: A literature review. The Open Journal of Occupational Therapy. 2018;6(3):10

Reference Type: BACKGROUND

Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.

Reference Type: BACKGROUND

PMID: 19451190 (View on PubMed)

Other Identifiers

REC/RCR & AHS/22/0749

Identifier Type: -

Identifier Source: org_study_id